{"id":2102838,"url":"https://alion.io/job/precera-medical-quality-engineer","title":"Quality Engineer","company":{"id":3868289,"name":"Precera Medical","domain":"preceramedical.com","url":"https://alion.io/company/preceramedical","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Dayforce","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Coon Rapids, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":80000,"max":100000,"currency":"USD","period":"year","gross":null,"usd_annual":100000},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Windows","optional":false}],"status":"live","first_seen_at":"2026-08-26T06:00:00Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-15T15:56:48Z","board_verified":true,"closed_at":null,"days_open":50,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":50},"description":"Position Summary: \nThe Quality Engineer is responsible for developing new processes/products, validating new equipment and technology, assisting production with continuous improvement on the shop floor, managing customer complaints, and handling CAPA/NCR activities. This role also involves leading change requests with customers and ensuring compliance with ISO 13485, FDA, and other applicable standards. The Quality Engineer collaborates closely with QA Technicians and Quality Inspectors (QAR).\nKey Responsibilities: \nProcess and Product Development:\nDevelop new processes/products and revise existing ones.\nCreate and update project-specific quality plans, ensuring adherence to customer requirements.\nWork as part of a cross-functional team.\nDevelop methods to measure products to ensure they meet quality standards.\nTroubleshoot measurement methods and equipment to ensure accuracy and reliability.\nValidation:\nLead validation of new products and technology (IQ, OQ, PQ).\nAct as QA lead for equipment validation.\nCustomer and Supplier Interface:\nCollaborate with customers and suppliers on new product processes.\nLead customer complaints and supplier SCAR management.\nStatistical Analysis:\nCompile and analyze statistical data to assess process capabilities.\nConduct PFMEA, GR&R, and SPC studies.\nQuality System Documentation:\nCreate and maintain quality system documentation, including quality plans, inspection and control plans, and work instructions.\nNCR and CAPA Management:\nManage NCR, CAPA, and customer complaints from creation to closure.\nUse problem-solving tools and work as part of a cross-functional team.\nChange Management:\nLead changes in production, ensuring compliance with customer agreements, ISO standards, and internal requirements.\nPrepare, submit, and follow change requests (SCR) with customers.\nProduction Support:\nAssist production in achieving APU objectives.\nGenerate quality KPIs for PSM2.\nAudits:\nPerform internal and external audits.\nSecondary Responsibilities:\nBackup Support:\nServe as backup for other QEs on customer or internal tasks as requested by the Director of Quality.\nContinuous Improvement:\nIdentify and support continuous improvement opportunities.\nParticipate in LEAP workshops.\nTraining:\nContribute to employee training.\nOther Duties:\nPerform other duties as assigned.\nNote: The Quality Engineer has a functional link with the QAR/QA inspectors.\nIn case of any issue escalated by the QAR about the DHR final acceptance and/or final CoC, the QE has authority to release or hold the DHR, approve the final CoC and/or decide the final status of the parts and release or hold the batch.\nThey can also escalate to the Director of Quality.\n\nRequired Qualifications:\nBachelor degree in Manufacturing Engineering or related field. \nMinimum two years relevant experience / five years for senior position.\nBlueprint reading is mandatory – GD&T level expected\nExperience developing manufacturing quality plans.\nExperience conducting process capability, GR&R, PFMEA and SPC studies. \nExperience working on NCR / CAPA. \nExperience working in an ISO environment, preferably ISO 13485.\nProficient PC skills in a Windows environment.\nEffective written and verbal communication skills. \nStrong interpersonal and teamwork skills.\n\nPreferred Qualifications:\nExperience in a precision machine shop environment. \nExperience optimizing processes to achieve ongoing cost reductions.\nLEAN / Six Sigma training and demonstrated application.\nDemonstrated use of structured problem-solving methods (i.e. 8D).\nExperience in internal and supplier audits.\nExperience using an ERP system.\n\nCompensation and Benefits Overview\nStarting Pay Range for this position is $80,000-$100,000/Annually.\nMinimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based on various factors, including but not limited to, local labor market conditions, years of relevant experience, education, professional certifications, foreign language proficiency, and other job-specific qualifications.\nEmployees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life/AD&D insurance, and the company’s 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees.\nFull-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time.","description_format":"text","description_chars":4736,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Design & Creative","Health Care","Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-08T19:15:53Z"}],"visa":[],"liveness":{"score":10,"band":"cold","label":"Long shot","p_open":1,"p_active":0.343,"p_room":0.28,"age_days":49,"expected_fill_days":24,"reasons":["conf:1","win:tail","crowd:junior"],"computed_at":"2026-10-15T05:46:00Z"},"pay":{"stated_usd_annual":100000,"is_top_pay":true},"html_url":"https://alion.io/job/precera-medical-quality-engineer","json_url":"https://alion.io/job/precera-medical-quality-engineer.json","meta":{"generated_at":"2026-10-15T17:37:42Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":26705,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3868289},"rest":"https://alion.io/mcp/rest/get_company?id=3868289"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fprecera-medical-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fprecera-medical-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fprecera-medical-quality-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/precera-medical-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fprecera-medical-quality-engineer"}]}